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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name x-ray, tomography, computed, dental
510(k) Number K210820
Device Name EAGLE EDGE AXR90 and AXR120
Alliage S/A Industrias Medico Odontológica
Rod. Abrão Assed, Km 53+450m
Recreio Anhanguera,  BR 14097-500
Applicant Contact Daniel Camargo
Kamm & Associates
8870 Ravello Ct
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1750
Classification Product Code
Date Received03/19/2021
Decision Date 08/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No